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The rumor I heard this morning was true. CMS has published its proposed rules for Stage 3 of Meaningful Use, once again waiting until late on a Friday to release a major document. Stage 3 will start no earlier than 2017.

Simultaneously, ONC released its proposed update to EHR certification regulations, to be known as the 2015 edition.

Both documents will appear in the Federal Register March 30, triggering a public comment period. CMS will take comments on the MU rule through May 29, while ONC will do so on the certification plan through June 30. Expect to see final rules before the end of the year.

From an HHS e-mail announcement:

Together, these proposed rules will give providers additional flexibility, make the program simpler and reduce burden, drive interoperability among electronic health records, and increase the focus on patient outcomes to improve care.

The proposed rules are one part of a larger effort across HHS to deliver better care, spend health dollars more wisely, and have healthier people and communities by working in three core areas: to improve the way providers are paid, improving the way care is delivered, and improving the way information is shared; to support transparency for consumers, health care providers, and researchers; and to strengthen decision-making.

“The flow of information is fundamental to achieving a health system that delivers better care, smarter spending, and healthier people. The steps we are taking today will help to create more transparency on cost and quality information, bring electronic health information to inform care and decision making, and support population health,” said HHS Secretary Sylvia M. Burwell.

The Meaningful Use Stage 3 proposed rule issued by CMS specifies new criteria that eligible professionals, eligible hospitals, and critical access hospitals must meet to qualify for Medicaid EHR incentive payments (Medicare incentive payments end in 2016). The rule also proposes criteria that providers must meet to avoid Medicare payment adjustments (Medicaid has no payment adjustments) based on program performance beginning in payment year 2018.

The 2015 Edition Health IT Certification Criteria proposed rule aligns with the path toward interoperability – the secure, efficient, and effective sharing and use of health information – identified in ONC’s draft shared Nationwide Interoperability Roadmap. The proposed rule builds on past editions of adopted health IT certification criteria, and includes new and updated IT functionality and provisions that support the EHR Incentive Programs care improvement, cost reduction, and patient safety across the health system.

The Stage 3 proposed rule’s scope is generally limited to the requirements and criteria for meaningful use in 2017 and subsequent years. CMS is considering additional changes to meaningful use beginning in 2015 through separate rulemaking.

Enjoy perusing the 301 pages of the Stage 3 proposal and 431 pages of the certification proposal this weekend!

Why do these things always seem to happen late on Friday afternoons? At least this time it’s not right before a holiday. Actually, with a bit more inspection, I see that it did happen right before a holiday.

HIMSS is reporting today that the White House’s Office of Management and Budget is “in its final stages of review” of the proposed rules for Stage 3 of the Meaningful Use EHR incentive program. OMB always goes over proposed and final regulations to measure the fiscal — and, presumably, political — impact before allowing executive-branch agencies to make public releases.

A peek at OMB’s reginfo.gov site indicates that the MU Stage 3 proposal from CMS and related ONC plan for certification of EHRs are indeed at OMB for final review.

“We are proposing the Stage 3 criteria that [eligible professionals], eligible hospitals, and [Critical Access Hospitals] must meet in order to successfully demonstrate meaningful use under the Medicare and Medicaid EHR Incentive Programs, focusing on advanced use of EHR technology to promote improved outcomes for patients. Stage 3 will also propose changes to the reporting period, timelines, and structure of the program, including providing a single definition of meaningful use. These changes will provide a flexible, yet, clearer framework to ensure future sustainability of the EHR program and reduce confusion stemming from multiple stage requirements,” CMS states in a rule summary on the OMB site.

Just days before the clock was to run out on hospitals, including Critical Access Hospitals, hoping to attest to Meaningful Use of EHRs for 2014, the Centers for Medicare and Medicaid Services has pushed back the attestation deadline by a month, until Dec. 31.

In an announcement posted yesterday on the CMS Meaningful Use registration and attestation login page, CMS said: “CMS is extending the deadline for Eligible Hospitals and Critical Access Hospitals (CAHs) to attest to meaningful use for the Medicare Electronic Health Record (EHR) Incentive Program 2014 reporting year from 11:59 pm EST on November 30, 2014 to 11:59 pm EST on December 31, 2014.”

Just don’t expect to do so online during a short period in a couple of weeks, as CMS says the site will be down for maintenance from Friday, Dec. 12 at 10 a.m. EST to Saturday, Dec. 13 at 12:30 p.m. EST. CMS also says people “may experience intermittent connectivity” Nov. 30 between 12:01 and 5 a.m. EST.

This extension “will allow more time for hospitals to submit their meaningful use data and receive an incentive payment for the 2014 program year, as well as avoid the 2016 Medicare payment adjustment,” CMS says.

You’ve no doubt hear about the kickback scandal involving CareFusion and Charles R. Denham, MD, founder of the Texas Medical Institute of Technology (TMIT). I wrote a piece about it in the context of Meaningful Use for Healthcare IT News this month, since Denham co-chaired the steering committee of the National Quality Forum’s Safe Practices for Better Healthcare program during the time CareFusion allegedly paid Denham $11.6 million to promote its products.

CMS, of course, has, to date, based Meaningful Use quality measures on NQF recommendations.

Denham has become a pariah of sorts in patient-safety circles since the U.S. Department of Justice announced a $40.1 million settlement with CareFusion in January. Yet, believe it or not, TMIT is still in business. The organization’s Web site is functional; in fact, the “about” page prominently features a video with Denham. And the TMIT Twitter account is activem, promoting a webinar as recently as yesterday.

Perry Bechtle, D.O., is a neuroanesthesiologist at Mayo Clinic in Jacksonville, Fla., and a former U.S. Navy flight surgeon. I want to believe that his credentials are impeccable, but it’s hard to take TMIT seriously these days in the absence of a major house-cleaning. Interestingly, the last academic article Denham wrote before the scandal broke was in the December 2013 issue of the Journal of Patient Safety. It’s entitled, “Safe Use of Electronic Health Records and Health Information Technology Systems: Trust But Verify,” and co-authors include heavyweights such as David Classen, M.D., and David Bates, M.D.

How are we supposed to trust an organization that itself was wrapped up in such a serious breach of trust?

As I reported for MedCity News at HIMSS14 nearly two weeks ago, CMS Administrator Marilyn Tavenner announced plans to provide unspecified flexibility in claims for Meaningful Use Stage 2 hardship exemptions this year. Tavenner then left without speaking to the media.

The news left a lot of people scratching their heads and waiting for some details. Today, CMS issued some clarification, confirming that there would be exemptions for healthcare providers unable to have EHRs certified to 2014 standards in place for the 2014 reporting year. This is particularly important now because Medicare penalties for not achieving Meaningful Use take effect next year, but they are based on the 2014 reporting year (Oct. 1, 2013-Sept. 30, 2014 for hospitals, the 2014 calendar year for physicians and other individual “eligible providers.”)

The guidance confirms that CMS is aware of the problems caused by the slow pace of certification to the new, 2014 standards that Stage 2 requires. As of today, according to the ONC Certified Health IT Products List (CHPL), there are 3,736 ambulatory and 1,200 EHRs and EHR modules certified to 2011 standards, but just 899 total that meet 2014 certification.

ORLANDO, Fla.—As HIMSS President and CEO hinted at yesterday in his podcast with me, HIMSS today announced the formation of the Personal Connected Health Alliance, in conjunction with the Continua Health Alliance and the HIMSS-owned mHealth Summit.

This short video from HIMSS explains:

Also, Lieber mentioned that HIMSS has not signed on to a letter from 48 organizations—led by CHIME—to HHS Secretary Kathleen Sebelius, calling for more time and flexibility in meeting Meaningful Use Stage 2 requirements., Lieber said HIMSS declined to sign because the requests were, in his opinion, “very vague.”

The undersigned organizations write to express immediate concerns confronting our respective members’ ability to comply with the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program. We recognize the vital role your department has taken in advancing the adoption of health information technology in the United States and appreciate your willingness to be flexible in extending the start of Stage 3 to 2017. We fear the success of the program is in jeopardy, however, if steps are not taken now to address our shared concerns.

Over the next seven months, more than 5,000 hospitals and 550,000 eligible professionals must adopt the 2014 Edition of Certified Electronic Health Record Technology (CEHRT) and meet a higher threshold of Meaningful Use criteria. Failure to do so will not only result in a loss of incentive payments, but also the imposition of significant penalties. With only a fraction of 2011 Edition products currently certified to 2014 Edition standards, it is clear the pace and scope of change have outstripped the ability of vendors to support providers. This inhibits the ability of providers to manage the transition to the 2014 Edition CEHRT and Stage 2 in a safe and orderly manner.

We are concerned this dynamic will cause providers to either abandon the possibility of meeting Meaningful Use criteria in 2014 or be forced to implement a system much more rapidly than would otherwise be the case. The first choice limits the success of the program to achieve widespread adoption of EHR, while the second is highly disruptive to healthcare operations and could jeopardize patient safety. As you know, our members’ number one priority must be to provide safe and high quality care to patients.

Providers need adequate time to learn how to use the newly deployed technology, including examining staff assignments, workflows, and practice processes. If providers move forward, as dictated by the current policy, our concerns regarding rushed implementations are heightened. Furthermore, we believe the “all or nothing” approach – where missing a single objective by even a small amount results in failure for the program year – compounds our concerns.

For these reasons, our organizations strongly recommend that HHS:1. Extend the timelines providers have to implement 2014 Edition Certified EHR software and meet the Program requirements (Stages 1 and 2) through 2015;2. Add flexibility in Meaningful Use requirements to permit as many providers as possible to achieve success in the program.

Given that we are well into 2014, immediate attention to these concerns is warranted. This additional time and new flexibility are vitally important to ensure that hospitals and physicians continue moving forward with technology to improve patient care. By making such changes, HHS would be demonstrating needed flexibility to maximize program success, without compromising momentum towards interoperability and care coordination supported by health IT.

We remain committed to the success of the program and look forward to hearing from you on this important matter. Please contact Jeffery Smith, Senior Director of Federal Affairs, CHIME, (jsmith@cio-chime.org) should you have any questions. Thank you for your consideration.

Sincerely,

AMDA-Dedicated to Long Term Care Medicine
American Academy of Allergy, Asthma & Immunology
American Academy of Dermatology Association
American Academy of Family Physicians
American Academy of Home Care Medicine
American Academy of Hospice and Palliative Medicine
American Academy of Neurology
American Academy of Ophthalmology
American Academy of Orthopaedic Surgeons
American Academy of Otolaryngology—Head and Neck Surgery
American Association of Neurological Surgeons / Congress of Neurological Surgeons
American College of Cardiology
American College of Osteopathic Family Physicians
American College of Osteopathic Internists
American College of Osteopathic Surgeons
American College of Physicians
American College of Radiology
American College of Rheumatology
American College of Surgeons
American Health Information Management Association
American Hospital Association
American Medical Association
American Osteopathic Academy of Orthopedics
American Osteopathic Association
American Psychiatric Association
American Society for Clinical Pathology
American Society for Gastrointestinal Endoscopy
American Society for Radiation Oncology
American Society of Anesthesiologists
American Society of Cataract and Refractive Surgery
American Society of Hematology
American Urological Association
America’s Essential Hospitals
Association of American Medical Colleges
Catholic Health Association of the United States
Children’s Hospital Association
College of Healthcare Information Management Executives
Federation of American Hospitals
Heart Rhythm Society
Infectious Diseases Society of America
Medical Group Management Association
National Rural Health Association
North American Spine Society
Premier healthcare alliance
Society for Cardiovascular Angiography and Interventions
Society of Thoracic Surgeons
The Endocrine Society
VHA Inc.

Yes, that is kind of vague, but that’s what you get when you involve four dozen organizations. Will it be effective? As I mentioned yesterday, ONC Chief Medical Officer Jacob Reider, M.D., hinted that there will be news about Stage 2 flexibility, likely Thursday morning at a joint ONC-CMS town hall. Reider made that statement at the CIO Forum, hosted by CHIME.

Under the revised timeline, Stage 2 will be extended through 2016 and Stage 3 will begin in 2017 for those providers that have completed at least two years in Stage 2. The goal of this change is two-fold: first, to allow CMS and ONC to focus efforts on the successful implementation of the enhanced patient engagement, interoperability and health information exchange requirements in Stage 2; and second, to utilize data from Stage 2 participation to inform policy decisions for Stage 3.

The phased approach to program participation helps providers move from creating information in Stage 1, to exchanging health information in Stage 2, to focusing on improved outcomes in Stage 3. This approach has allowed us to support an aggressive yet smart transition for providers.

The delay to Stage 3 was likely. As I exclusively reported in June, ONC’s deputy national coordinator for programs and policy, Judy Murphy, dropped a strong hint that Stage 3 would not start until 2017, saying, “2016 would be a problem.” By pushing back the start of the third stage, we would automatically get an extension to Stage 2, making it a three-year program instead of two.

The start of Stage 2 already had been pushed back a year from the original plan of 2013. From my reading, what CMS is proposing today is not another delay to the beginning of Stage 2. Hospitals that have begun their attestation periods since Oct. 1 may continue and physicians are allowed to start Jan. 1.

CMS said to expect proposed Stage 3 regulations, as well as proposed ONC EHR certification rules for Stage 3, in the fall of 2014.

What strikes me as odd is that this announcement came late on a Friday afternoon. There is no time stamp on the ONC blog post, but CMS’ Travis Broome tweeted this at 4:05 pm EST:

Late Friday is typically when government agencies take steps they don’t want plastered all over the news. I don’t see anything here that is surprising or controversial, and it could be argued that ONC didn’t mislead people with earlier statements because the start dates for Stage 2 are not changing. Did I miss something?

UPDATE: CMS held a webcast about this that started at 1 p.m. EST. That’s still Friday afternoon, but not so late that it looks like they’re trying to bury the news.

First off, it’s clear that Mostashari feels unshackled from having to watch his words now that he’s no longer national health IT coordinator. Secondly, he’s right. This story contains so many errors and misleading statements that it’s almost funny. Let’s count down the top 10.

10. “Under a George W. Bush-era executive order, all Americans should have access to their medical records by the end of 2014, part of a concept referred to as e-health. President Obama then made electronic medical records (EMRs) central to the success of the Affordable Care Act”

When Bush issued the executive order in 2004 that created the Office of the National Coordinator for Health Information Technology, he set as a goal interoperable EMRs for “most” Americans. The “all” part came after Barack Obama took office in 2009.

9. Though Obama did reiterate the 2014 goal and up the stakes by saying “all Americans,” nobody realistically thought it could happen. After all, the HITECH Act, which created Meaningful Use, didn’t pass until March 2009 and Meaningful Use didn’t even start until 2011. Before the HITECH Act, ONC barely had any funding anyway. For five years, Congress failed to pass much in the way of health IT legislation, even though a federal EHR incentive program had bipartisan support, symbolized by an unlikely alliance between Newt Gingrich and Hillary Clinton.

8. “Doctors, practitioners and hospitals, though, have been enriching themselves with the incentives to install electronic medical records systems that are either not inter-operable or highly limited in their crossover with other providers.”

Meaningful Use was never intended for enrichment, or even to cover the full cost of an EHR system.

7. While systems mostly are not interoperable yet, that wasn’t the intent of Stage 1 of Meaningful Use. Stage 1 was meant to get systems installed. Stage 2, which has barely started for the early adopters among hospitals and won’t start for 2 1/2 months for physicians, is about interoperability. That’s where the savings and efficiencies are supposed to come from.

6. We’re years away from knowing whether Meaningful Use program did its job, though I don’t fault members of Congress such as Sen. John Thune (R-S.D.) for putting pressure on the administration to demand more for the big taxpayer outlay.

5. “‘The electronic medical records system has been funded to hospitals at more than $1 billion per month. Apparently little or none of that money went to the enrollment process which is where the bottle neck for signing up to ObamaCare’s insurance exchanges appears to be,’ Robert Lorsch, a Los Angeles-based IT entrepreneur and chief executive of online medical records provider MMRGlobal, told Fox News.”

The money wasn’t supposed to go to the insurance enrollment process. The Meaningful Use incentive program was from the HITECH Act, part of the 2009 American Recovery and Reinvestment Act. The Patient Protection and Affordable Care Act, a.k.a. Obamacare, came a year later. Again, someone is confusing insurance and care. They are not the same thing.

4. “Lorsch, at MMRGlobal, offered the U.S. government what it describes as a user-friendly personal health record system for one dollar per month per family – a fraction of what it has cost the taxpayer so far.”

MMRGlobal’s product is an untethered personal health record. No untethered PHR anywhere is “user-friendly,” which is why adoption has been anemic. Without data from organizational EHRs, PHRs are worthless. Besides, the direct-to-consumer approach in healthcare has failed over and over, since people are used to having someone else — usually an insurance company — pick up the tab.

3. For that matter, MMRGlobal is a bad example to use as an alternative to EHRs. (The Fox story is correct in saying that other vendors do have close ties to the Obama administration, though the former Cerner executive’s name is Nancy-Ann DeParle, not “Nance.”) I could be wrong, but I haven’t seen a whole lot of evidence that MMRGlobal isn’t much more than a patent troll.

2. “But this process could have been easier if a nine-year, government-backed effort to set up a system of electronic medical records had gotten off the ground. Instead of setting up their medical ID for the first time, would-be customers would have their records already on file.”

Actually, as I wrote in a story just published in Healthcare IT News, we could have had national patient identifiers 15 years ago, as called for by the 1996 HIPAA statute. But Congress voted in 1998 not to fund implementation of a national patient ID and President Bill Clinton signed that into law. Since then, interoperability and patient matching have been mighty struggles.

1. “‘Plus, unlike under ObamaCare, the patient would be in control of their health information and, most importantly, their privacy,’ Lorsch said.”

Where in Obamacare does the patient lose control of health information? Less than a month ago, I was in Washington listening to HHS Office for Civil Rights Director Leon Rodriguez say, ““There is a clear right [in the HIPAA privacy rule] not only of patient access, but patient control over everything in their records.” This may come as news to some people, but patients own and control the information. They might not know it, but the language is pretty clear.

Already, the Fox story has been reposted in a number of blogs shared all over the Internet, so it’s being accepted as fact in some quarters. If you want the truth, you sometimes have to do the work yourself.

I finally got around to finishing “Bitter Pill: Why Medical Bills Are Killing Us,” the 24,000-word special report about healthcare costs that took up the entire feature section of the Feb. 20 edition of Time magazine. I was expecting to agree with most if not all of Steven Brill’s supposedly epic investigative piece. Instead, I was underwhelmed and quite disappointed that Brill, the founder of CourtTV (R.I.P., reincarnated as TruTV in Turner Broadcasting’s quest for more “reality” programming) and of American Lawyer magazine, only told half the story about all that ails the U.S. healthcare industry. Brill also editorializes far more than he should.

Granted, the story is about the high cost of care, but you can’t discuss cutting costs without also delving into the subject of improving outcomes. As has been stated in many other places, we have more of a sick-care system than a healthcare system. The incentives favor treating illness, not preventing it.

I have to say I learned a lot about how the racket known as the chargemaster works to keep the true costs of care opaque to patients. I suspect that, with the exception of uninsured people who are the only ones expected to pay full price, the public was unaware of the chargemaster system that hospitals guard like a state secret. Brill is right when he says, “Unless you have Medicare, the health care market is not a market at all. It’s a crapshoot.” But he’s not telling the full story. Medicare’s payment list is public, sure, but do Medicare beneficiaries really care what the federal government pays their hospitals and doctors? No, they, like everyone else with insurance coverage, only pay attention to their out-of-pocket cost.

Sure, Brill spends a lot of time discussing the perverse incentives in healthcare, particularly those that encourage expensive testing, and even touches on some of the reforms in the Patient Protection and Affordable Care Act that seem to have been left out of the debate over insurance coverage. Think the Medicare policy of not reimbursing hospitals for certain preventable readmissions.

But he completely neglects accountable care. Nor is there a mention of electronic health records and how interoperability can help reduce duplicate testing and unnecessary care. And he never addresses the elephant in the room, the shamefully high rate of medical errors that makes American healthcare far from the best in the world.

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